Civil Rights Group Argues for Protection of Prescription Databases
| Posted: 29 January 2013
By Alexander Gaffney, RF News Editor
The American Civil Liberties Union (ACLU), a constitutional and legal advocacy group, is filing a lawsuit against the Drug Enforcement Administration (DEA) in light of what it calls a constitutionally dubious encroachment on the prescription drug use records of US citizens.
In a statement posted to its website on 25 January 2012, the organization said it had been made aware of DEA's efforts to "access private prescription records of patients in Oregon without a warrant, despite a state law forbidding it from doing so." The ACLU's Nathan Freed Wessler, an attorney with the group's Speech, Privacy and Technology Project, said the case raised questions of whether federal law enforcement agencies would "obtain confidential prescription records without a judge's prior approval."
"It should not," Wessler wrote.
Could REMS Be Affected?
The case could have broader implications for the regulated pharmaceutical industry, which occasionally uses such databases as a means to monitor access to a particular drug product. For manufacturers of long-acting or extended-release opioid products, this means keeping a close tabs on their drugs, which are classified as schedule II drugs under the Controlled Substances Act. As it stands, DEA requires that prescribers of schedule II and III products be registered with its DEA Registration Database.
The US Food and Drug Administration's (FDA) Risk Evaluation and Mitigation Strategies (REMS) policy for elements to ensure safe use (ETASU) indicates that such policies may include elements such as the monitoring of each patient using a particular drug and enrolling each patient into a registry, either of which could hypothetically be accessed by federal officials.
Oregon has sidestepped FDA and made its own registration requirements, known as the Oregon Prescription Drug Monitoring Program (PDMP), which tracks the dispensing of drugs including Xanax, Valium, Marinol, Ritalin, Adderall, and numerous others. "The program was intended to help physicians prevent drug overdoses by their patients and more easily recognize signs of drug abuse," ACLU explained.
And though such drugs have been subject to abuse by some consumers, ACLU's lawyers argue that the potential for abuse does not abrogate the rights of those with legitimate illnesses. And therein lies the problem: Oregon's legislature—in theory, at least—had agreed with ACLU's interpretation of this from the beginning of the program, requiring DEA and others to request prescription records only after obtaining a warrant.
Use of Administrative Subpoenas
In the meantime, however, DEA has been using what are known as "administrative subpoenas," which are subpoenas issued by a federal agency and do not require the oversight or approval of a member of the judiciary. Critics of the use of the subpoenas have long argued that their use is a violation of the Fourth Amendment's right to be free from unreasonable search and seizure (more from Wired), but DEA uses them for all sorts of activities, from probing drug prescription registries to utility bills from power companies.
Oregon, like ACLU, has sued DEA to halt the use of the administrative subpoenas, arguing that the disclosure of users of such drugs could, for example, disclosure that a patient is suffering from AIDS (Marinol, which contains synthetic THC, prevents nausea and increases appetite), depression, mental illness, terminal illness or transgender status.
"Our clients are concerned that the privacy of their medical information will be violated if the DEA is allowed to search through prescription records without a warrant," wrote Wessler. The agency would still be able to obtain those records if they received a warrant signed by a judge, the group argued.
These patients have a "reasonable expectation of privacy in their prescription records," the group argues in its court filing.
Depending upon the judge's ruling in the case, ACLU's arguments could have broader implications. If, for instance, the judge rules that DEA's use of administrative subpoenas is unconstitutional, the agency's ability to use such measures on any registry—including those maintained by private companies as part of a REMS policy—could be put into jeopardy. The judge may, however, choose to sidestep constitutional questions entirely, as much of the case is predicated on Oregon—not federal—law.
ACLU Court Filing Documents